LEVOCETIRIZINE DIHYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

LEVOCETIRIZINE DIHYDROCHLORIDE

Composition:

LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. The use of levocetirizine dihydrochloride tablets is contraindicated in: Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions ( 6.2)] . Patients with end-stage renal disease (CL CR < 10 mL/min) and patients undergoing hemodialysis. Children 6 months to 11 years of age with impaired renal function. Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence

Product summary:

Levocetirizine Dihydrochloride Tablets USP are available as follows: 5 mg - white to off-white, film-coated, oval-shaped, scored tablets. One side of the tablet is scored in half and debossed with the number "9" on one side of the score and "3" on the other. The other side of the tablet debossed with the number "7701". They are available in bottles of 30 (NDC 43063-479-30). Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVOCETIRIZINE DIHYDROCHLORIDE- LEVOCETIRIZINE DIHYDROCHLORIDE TABLET,
FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVOCETIRIZINE
DIHYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS.
LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Levocetirizine dihydrochloride tablets are a histamine H
-receptor antagonist indicated for: (1)
The treatment of the uncomplicated skin manifestations of chronic
idiopathic urticaria (1.2)
DOSAGE AND ADMINISTRATION
CHRONIC IDIOPATHIC URTICARIA (2.2)
Adults and children 12 years of age and older: 5 mg once daily in the
evening
Children 6 to 11 years of age: 2.5 mg once daily in the evening
Renal Impairment
Adjust the dose in patients 12 years of age and older with decreased
renal function ( 12.3)
DOSAGE FORMS AND STRENGTHS
Immediate release breakable (scored) tablets, 5 mg ( 3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to levocetirizine or any of the
ingredients of levocetirizine
dihydrochloride tablets or to cetirizine ( 4.1)
Patients with end-stage renal disease at less than 10 mL/min
creatinine clearance or patients
undergoing hemodialysis ( 4.2)
Children 6 months to 11 years of age with renal impairment ( 4.3)
WARNINGS AND PRECAUTIONS
Avoid engaging in hazardous occupations requiring complete mental
alertness such as driving or
operating machinery when taking levocetirizine dihydrochloride ( 5.1).
Avoid concurrent use of alcohol or other central nervous system
depressants with levocetirizine
dihydrochloride ( 5.1).
Use with caution in patients with predisposing factors of urinary
retention (e.g. spinal cord lesion,
prostatic hyperplasia). Discontinue levocetirizine dihydrochloride if
urinary retention occurs ( 5.2).
ADVERSE REACTIONS
The most common adverse reactions (rate ≥ 2% and > placebo) were
somnolence, nasopharyngitis,
fatigu